Quick links to relevant pages on the TGA website
Guidance for Industry
- Personalised medical devices landing page: The medical devices reforms page contains the regulatory changes and all the key links and updates.
- NEW: Global Medical Device Nomenclature (GMDN) Terms: Information to support sponsors and manufacturers.
- UPDATED: Custom-made medical devices landing page: Information for sponsors, health professionals and manufacturers.
- Australian Register of Therapeutic Goods (ARTG). Search the ARTG to find if devices you currently use are already listed.
- FAQs: These Frequently Asked Questions cover many of the main areas of concern and confusion.
- Glossary of Terms: Search this for definitions of terms e.g. Manufacturer, Supplier, Active medical device.
- Inclusion Process: This is a step by step guide for Sponsors applying to include a 'kind of device' in to the ARTG
- Kind of medical device:This page explains the characteristics shared by a 'kind of medical device'.
- An Overview of medical devices regulation: Information to assist you if you are new to the TGA and Australia's regulatory framework.
- NEW: Therapeutic Goods Legislation Amendment (2021 Measures No.3) Regulations 2021: The latest TGA amendments to the the regulation of personalised medical devices.
- Personalised medical devices (including 3D-printed devices): A guidance document for the new regulatory framework for PMD.
- Refinements to the Personalised Medical Device Framework; A guidance document with the latest agreed refinements to the personalised medical devices framework.
- Dental Sector Working Group's TGA submission.
Forms and tools
- Classification Tool: Use this to help you decide what classification your device falls under.
- Is your Product a medical device? Work it out by using this tool.
- Notification Form. Complete this for each 'kind' of medical device you manufacture/supply to include your device/s in the old system:
- Transition Form. Complete this before 25 August 2022 to apply to transition your device from custom-made to patient-matched: